DPTA: Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

Sponsor

Center Trials & Treatment Europe (Other)

Overall Status

Unknown status

CT.gov ID

NCT03827070

Collaborator

Center Trials & Treatment (Other)

Enrollment

Location

Arm

12.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is formed.

Currently, the most common and effective method of obliteration of the pleural cavity is pleurodesis with talcum powder.

Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering of the lungs and chest wall. As a result, the liquid ceases to accumulate.

The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the pleural cavity, but also reduces tumor and metastatic processes.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: Afatinib Drug: Talcum powder	Phase 1

Detailed Description

The proposed procedure for dry pleurodesis consists of one stage.

Talc is introduced into the pleural cavity in several ways:

Drainage - a tube is inserted into the pleural cavity through a puncture in the chest, and then a pasty talcum is delivered into the cavity, which spreads through the cavity during the change of the patient's body position.
Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural cavity of the patient, which allows him to evenly distribute and significantly increases the effectiveness of the procedure.

In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and afatinib is subjected to the procedure of pharmaceutical mixing.

The operation is well tolerated by participants and lasts no more than 30 minutes. The effectiveness of the method is 90%.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group AssignmentSingle Group Assignment

Masking:

None (Open Label)

Masking Description:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

New Method of Treatment for Thoracoscopy or Bronchoscopy by Suspension of Fine Powder of Talcum and Afatinib is Used in Patients With Positive Mutation of EGFR in Non-Small Cell Lung Carcinoma (NSCLC)

Actual Study Start Date :

Mar 5, 2019

Anticipated Primary Completion Date :

Nov 9, 2019

Anticipated Study Completion Date :

Mar 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Talcum powder & Afatinib Talcum powder 4 g + Afatinib 0,4 g. Is entered once	Drug: Afatinib Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19% Other Names: BIBW2992 Drug: Talcum powder Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11% Other Names: Talc

Arm

Intervention/Treatment

Experimental: Talcum powder & Afatinib

Talcum powder 4 g + Afatinib 0,4 g. Is entered once

Drug: Afatinib

Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%

Other Names:

BIBW2992

Drug: Talcum powder

Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11%

Other Names:

Talc

Outcome Measures

Primary Outcome Measures

The effectiveness of the procedure of dry pleurodesis through a thoracoscope [up to 90 days]
Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope. The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Non-small cell lung cancer with positive mutation of EGFR verified
Malignant pleural effusion
Recurrent pleural effusion
Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography.
Karnofsky index > 50
Agreed to participate in the study and sign an Informed Consent